Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-03-01 @ 4:28 AM
Study NCT ID:
NCT02605759
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2015-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coldplay Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia
Sponsor:
Pentax Medical
Organization:
Study Overview
Official Title:
Clinical Study to Evaluate the Safety, Feasibility and Efficacy of the Coldplay CryoBalloon Focal Ablation System for the Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.
Detailed Description:
Multi-center, prospective, single arm, non-randomized study. The study will proceed in two phases: a pilot phase, followed by the feasibility, safety and efficacy phase. In the pilot phase, up to five (5) patients at one (1) site will be treated with the CryoBalloon Ablation System to confirm its safety and feasibility in the treatment of squamous dysplasia. The second phase will be conducted at two (2) centers and will enroll up to 50 subjects to evaluate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of squamous dysplasia.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: